1 Il certificato viene rilasciato se al momento della richiesta:
2 Il certificato è rilasciato in base alla prima omologazione.260
258 Nuovo testo giusta l’all. n. 2 della LF del 18 mar. 2016, in vigore dal 1° gen. 2019 (RU 2017 2745, 2018 3575; FF 2013 1).
260 Nuovo testo giusta l’all. n. 2 della LF del 18 mar. 2016, in vigore dal 1° gen. 2019 (RU 2017 2745, 2018 3575; FF 2013 1).
1 The certificate takes effect on expiry of the maximum term of the patent for a period equal to the period which elapses between the date of filing under Article 56 and the date of the first authorisation of the medicinal product containing the product in Switzerland, minus five years.263
2 It is valid for no more than five years.
3 The Federal Council may specify that the authorisation of a medicinal product containing the product granted in the European Economic Area (EEA) constitutes the first authorisation within the meaning of paragraph 1 if it is granted earlier than the first authorisation in Switzerland.264
263 Amended by Annex No 2 of the FA of 18 March 2016, in force since 1 Jan. 2019 (AS 2017 2745, 2018 3575; BBl 2013 1).
264 Amended by Annex No 2 of the FA of 18 March 2016, in force since 1 Jan. 2019 (AS 2017 2745, 2018 3575; BBl 2013 1).
Il presente documento non è una pubblicazione ufficiale. Fa unicamente fede la pubblicazione della Cancelleria federale. Ordinanza sulle pubblicazioni ufficiali, OPubl.
This document is not an official publication. Only the publication of the Federal Chancellery is legally binding.